Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease

Renal Insufficiency Clinical Trial

Official title:

A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injection of ProHance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600834
• Other study ID #: PH-106
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: October 31, 2014
• Start date: February 2008
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Observational

Clinical Trial Summary

The objective of this long term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR <30).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

COHORT 1

• Is going to receive or has received PROHANCE injection during an MRI examination;

• Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.

• Provides written informed consent and is willing to comply with protocol requirements.

OR

COHORT 2

• Is going to receive or has received PROHANCE injection during an MRI examination;

• Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.

• Provides written informed consent and is willing to comply with protocol requirements.

Exclusion Criteria:

COHORT 1

• Has received a GBCA within the past 12 months prior to inclusion in this study;

• Has unstable kidney function;

• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;

• Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;

• Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

OR

COHORT 2

• Has received a GBCA within the past 12 months prior to inclusion in this study;

• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;

• Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;

• Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Diseases
• Nephrogenic Fibrosing Dermopathy
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Bracco Diagnostic Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate and compare the incidence of NSF in the two cohorts defined. The incidence is defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients.		1, 3, 6, 12, 18 and 24 months	Yes